videomed Truelink 4, Инструкция по эксплуатации

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System identification
80028008_030_B – 773625 – 2021-04-29
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Legislation and rules applicable to European Union (EU) countries:
1.3 Warranty
The complete warranty clauses are provided in the sales contract.
VIDEOMED S.r.l. assures the safety and functional reliability of the
system provided that:
– the system is used, managed and repaired exclusively as
described in these instructions for use;
– installations, modifications and repairs are carried out
exclusively by the VIDEOMED S.r.l. assistance services
– only spare parts and accessories authorized by the
Manufacturer are used;
– no structural changes to the devices are carried out.
The system status after system testing must be recorded in an
installation protocol. Commissioning is used as proof of the start
of the warranty period.
Further details may be present in the commercial contract.
The conditions required by the commercial contract (if different)
have priority over what is provided in this section.
Standard Description
Regulation (EU) 2017/745 Regulation on medical devices amending Directive 93/42/EEC
will enter into force on 26 May 2021
93/42/EEC Medical Devices Directive (MDD) and f.m. 2007/47/EC
EN 1041:2008 Information provided by the manufacturer of medical devices
EN ISO 13485:2016 Management systems for the quality of medical devices
EN ISO 14971:2012 Applying risk management to medical devices
EN ISO 15223-1:2016 Symbols to be used in medical device labels, labelling and
information to be provided — Part 1: General requirements
EN 60601-1:2006/A1:2013 General requirements for fundamental safety and essential
performance
EN 60601-1-2:2015 General requirements relating to fundamental safety and
essential performance - Collateral standard: Electromagnetic
compatibility
EN 60601-1-6:2010 General safety standards — Collateral rule: Usability
EN 62304:2006 + A1:2015 Medical Device Software — Software Lifecycle Processes
EN 62366-1:2015 Application of user characteristics engineering to medical
devices
WEEE 2012/19/EU Waste electrical and electronic equipment
RoHS 2011/65/EU Restriction of the use of certain hazardous substances in
electrical and electronic equipment